Systematic Provision of Intrauterine Contraception After First Trimester Abortion - Effects on Quality of Life and Risk of Repeat Abortion. A Randomized, Prospective Trial.
This study is currently recruiting participants.
Verified July 2010 by Helsinki University Central Hospital
Sponsor:
Helsinki University Central Hospital
Information provided by:
Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01223521
First received: October 18, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
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Purpose
A randomized prospective study on the effects of immediate provision of intrauterine contraception after first trimester induced abortion - effects on repeat abortions and life quality.
| Condition | Intervention |
|---|---|
|
Contraception After First Trimester Abortion. |
Device: Post-abortal provision of intrauterine device |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | Systematic Provision of Intrauterine Contraception After First Trimester Abortion - Effects on Quality of Life and Risk of Repeat Abortion. A Randomized, Prospective Trial. |
Resource links provided by NLM:
Further study details as provided by Helsinki University Central Hospital:
Primary Outcome Measures:
- Number of repeat abortions [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Expulsions [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 700 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Immediate intrauterine contraception
IUD (either Cu-IUD or LNG-IUS) inserted immediately after abortion.
|
Device: Post-abortal provision of intrauterine device
A Cu-IUD or LNG-IUS is inserted after abortion.
|
|
No Intervention: Control group
Post-abortal contraception is prescribed by the hospital but on the responsibility of the patient.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Duration of pregnancy < 12 weeks.
- Age ≥18 years
Exclusion Criteria:
- Contraindication for spiral insertion: uterine anomaly, infection, copper allergy (Cu-IUD).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01223521
Contacts
| Contact: Oskari Heikinheimo, MD, PhD | +358 40 5871070 | oskari.heikinheimo@helsinki.fi |
| Contact: Satu P. Suhonen, MD, PhD | +358 50 4025591 | satu.suhonen@hel.fi |
Locations
| Finland | |
| Dept Obstetrics and Gynecology, Helsinki University Central Hospital | Recruiting |
| Helsinki, Finland, 00029 HUS | |
| Contact: Oskari Heikinheimo, MD, PhD +358 40 5871070 oskari.heikinheimo@helsinki.fi | |
| Contact: Pirjo Ikonen +358 50 4279734 pirjo.h.ikonen@hus.fi | |
| Sub-Investigator: Maarit Mentula, MD | |
| Sub-Investigator: Elina Pohjoranta, MD | |
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
| Principal Investigator: | Oskari Heikinheimo, MD, PhD | Helsinki University Central Hospital |
| Study Director: | Satu P Suhonen, MD, PhD | City of Helsinki |
More Information
No publications provided
| Responsible Party: | Oskari Heikinheimo, physician in-chief, Helsinki University Central Hospital, Dept Ob&Gyn |
| ClinicalTrials.gov Identifier: | NCT01223521 History of Changes |
| Other Study ID Numbers: | TYH2010224 |
| Study First Received: | October 18, 2010 |
| Last Updated: | October 18, 2010 |
| Health Authority: | Finland: Helsinki University Central Hospital |
Keywords provided by Helsinki University Central Hospital:
|
Contraception Abortion First trimester Intrauterine device |
ClinicalTrials.gov processed this record on June 18, 2013